BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PASCAL PRECISION

    MDR report key: 23861999 · Received December 22, 2025

    Report

    Report Number
    2015691-2025-10408
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    December 2, 2025
    Report Date
    January 27, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NKM
    UDI-DI
    00690103213331
    PMA / PMN Number
    P220003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION ADDED/UPDATED TO SECTION B4, G3, G6, H2, AND H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATIONS CONCLUSIONS) ADDITIONAL H6 TYPE OF INVESTIGATION CODE: LABELLING REVIEW AND ANALYSIS OF IMAGES. H11: ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO NONCONFORMANCES RELATED TO THE COMPLAINT EVENT WERE IDENTIFIED. BASED ON THE COMPLAINT INVESTIGATION, THE COMPLAINT FOR INABILITY OR DIFFICULTY TO INSERT DEVICE INTO TRANSSEPTAL PUNCTURE LOCATION WAS CONFIRMED WITH OBJECTIVE EVIDENCE. PER THE INSTRUCTIONS FOR USE (IFU), ATRIAL/SEPTAL INJURY IS A KNOWN POTENTIAL ADVERSE EVENT WHICH HAS BEEN IDENTIFIED AS A POSSIBLE COMPLICATION OF THE PASCAL IMPLANT PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO VASCULAR INJURY. THE IMAGING EVALUATION (IE) NOTED A PERICARDIAL EFFUSION BUT COULD NOT IDENTIFY THE CONTRIBUTING FACTORS. THERE WERE NO ECHO SIGNS OF CARDIAC TAMPONADE. THE IE WAS UNABLE TO CONFIRM ANY DEVICE RELATED ISSUES OR MALFUNCTIONS. THE AVAILABLE INFORMATION IS UNABLE TO SUGGEST A LIKELY ROOT CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, A DEFINITE ROOT CAUSE IS UNABLE TO BE DETERMINED. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, CORRECTIVE OR PREVENTATIVE ACTIONS ARE NOT REQUIRED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    PER THE REPORT RECEIVED FROM GERMANY, EDWARDS RECEIVED NOTIFICATION OF A PASCAL PRECISION PROCEDURE IN MITRAL POSITION. AFTER IMPLANTATION AND BEFORE REMOVAL OF THE GUIDE SHEATH (GS) A PERICARDIAL EFFUSION (PE) IN FRONT OF THE RIGHT VENTRICLE BUT OVERALL ALL AROUND THE HEART, WAS NOTICED. PUNCTURES OF THE INTERATRIAL SEPTUM (IAS) WERE PERFORMED WITHOUT COMPLICATIONS. JUST BEFORE REMOVING THE GS AND AFTER MOVING TO THE RIGHT ATRIUM WITH THE SYSTEM, A PERICARDIAL EFFUSION IN FRONT OF THE RIGHT VENTRICLE BUT OVERALL ALL AROUND THE HEART, WAS NOTICED. PATIENT EXPERIENCED ELECTROCARDIOGRAM AND HEART RATE CHANGES. A PERICARDIOCENTESIS WAS PERFORMED. THE PE WAS PUNCTURED IMMEDIATELY AFTER THE PROCEDURE, AND 300 ML WERE ASPIRATED. AT THAT TIME, 7000 IU OF PROTAMINE WAS ADMINISTERED. THE ACT WAS 153 SECONDS AND THE BLOOD PRESSURE WAS 137/71MMHG. PATIENT'S FINAL OUTCOME WAS STABLE CONDITION. AFTER INTERNAL REVIEW OF PROCEDURAL IMAGING, THERE IS NO PERICARDIAL EFFUSION EVIDENT DURING TRANSSEPTAL PUNCTURE, NOR DURING THE FIRST PASCAL IMPLANTATION. AFTER THE GUIDE SHEATH IS REMOVED, IMAGING DEMONSTRATES A PERICARDIAL EFFUSION MEASURING UP TO 2.2CM IN DIASTOLE. THE EFFUSION IS CIRCUMFERENTIAL. THERE ARE NO ECHO SIGNS OF CARDIAC TAMPONADE. CONTRIBUTING FACTORS ARE INDETERMINABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205405 EDWARDS PASCAL PRECISION MITRAL VALVE REPAIR DEVICES NKM EDWARDS LIFESCIENCES 20000GS 67077919 00690103213331

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention